Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

PHASE3CompletedINTERVENTIONAL
Enrollment

2,627

Participants

Timeline

Start Date

April 25, 2018

Primary Completion Date

September 22, 2023

Study Completion Date

September 22, 2023

Conditions
Healthy Volunteers (Meningococcal Infection)
Interventions
BIOLOGICAL

MenACYW conjugate vaccine

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

BIOLOGICAL

MenACYW-135 conjugate vaccine

Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular

BIOLOGICAL

DTaP-IPV//Hib vaccine

DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular

BIOLOGICAL

Pneumococcal 13-valent conjugate vaccine

Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular

BIOLOGICAL

Pentavalent rotavirus vaccine

Rotavirus vaccine at 2, 4, and 6 months of age, oral solution

BIOLOGICAL

Hepatitis B vaccine

Hepatitis B vaccine at 2 and 6 months of age, Intramuscular

BIOLOGICAL

Measles, mumps, rubella (MMR) vaccine

MMR vaccine at 12 months of age, Subcutaneous

BIOLOGICAL

Varicella vaccine

Varicella vaccine at 12 months of age

BIOLOGICAL

Hepatitis A vaccine

Hepatitis A vaccine at 15 to 18 months of age

Trial Locations (70)

10467

Tiga Pediatrics Site Number : 8400137, New York

16505

Allegheny Health and Wellness Pavilion Site Number : 8400047, Erie

20910

Virgo-Carter Pediatrics Site Number : 8400041, Silver Spring

21702

University of Maryland at The Pediatric Center of Frederick Site Number : 8400004, Frederick

25701

Marshall Health Site Number : 8400062, Huntington

28607

Blue Pediatric & Adolescent Medicine Group Site Number : 8400100, Boone

29414

Coastal Pediatric Research Charleston Site Number : 8400005, Charleston

29607

Tribe Clinical Research Site Number : 8400110, Greenville

29681

Parkside Pediatrics - Simpsonville Site Number : 8400113, Simpsonville

30341

Baybol Research Institute Site Number : 8400008, Chamblee

32720

Avail Clinical Research Site Number : 8400077, DeLand

32746

Children's Research, LLC Site Number : 8400063, Lake Mary

32803

Florida Hospital Medical Group Pediatrics Site Number : 8400108, Orlando

33013

Next Phase Research Alliance Site Number : 8400057, Hialeah

33030

Homestead Medical Clinic, P.A. Site Number : 8400014, Homestead

Next Phase Research Alliance Site Number : 8400040, Homestead

33157

IMIC Inc Site Number : 8400022, Palmetto Bay

33186

Acevedo Clinical Research Associates Site Number : 8400001, Miami

33470

Axcess Medical Research Site Number : 8400068, Loxahatchee Groves

33617

Jedidiah Clinical Research Site Number : 8400132, Tampa

34613

Asclepes Research Centers Site Number : 8400064, Brooksville

35205

Birmingham Pediatric Associates Site Number : 8400026, Birmingham

36305

Southeastern Pediatric Associates Site Number : 8400003, Dothan

37388

Pediatric Clinical Trials Tullahoma Site Number : 8400033, Tullahoma

39531

MedPharmics Biloxi Site Number : 8400080, Biloxi

40207

Brownsboro Park Pediatrics Site Number : 8400010, Louisville

40243

All Children Pediatrics Site Number : 8400043, Louisville

45414

Ohio Pediatric Research Site Number : 8400084, Dayton

47715

Qualmedica Research, LLC Site Number : 8400106, Evansville

63044

Craig Spiegel, MD Site Number : 8400037, Bridgeton

68131

Creighton University Site Number : 8400039, Omaha

70006

Velocity Clinical Research Site Number : 8400025, Metairie

71037

ACC Pediatric Reasearch Site Number : 8400023, Haughton

71103

LSUHSC-Shreveport Site Number : 8400120, Shreveport

72401

The Children's Clinic of Jonesboro, PA Site Number : 8400032, Jonesboro

72703

Northwest Arkansas Pediatric Clinic Site Number : 8400011, Fayetteville

75218

Oak Cliff Research Company, LLC Site Number : 8400065, Dallas

76104

Helios Clinical research Site Number : 8400075, Fort Worth

76550

FMC SCIENCE Site Number : 8400053, Lampasas

77008

Helios Clinical Research Site Number : 8400109, Houston

78229

Tekton Research, Inc Site Number : 8400049, San Antonio

78244

Tekton Research Site Number : 8400128, San Antonio

78726

ARC Clinical Research at Wilson Parke Site Number : 8400059, Austin

83404

Snake River Research, PLLC Site Number : 8400073, Idaho Falls

84015

Ericksen Research and Development Site Number : 8400016, Clinton

84037

Wee Care Pediatrics Site Number : 8400035, Kaysville

84041

Tanner Clinic Site Number : 8400018, Layton

84064

Pediatric Care Site Number : 8400056, Provo

84067

Wee Care Pediatrics Roy Site Number : 8400029, Roy

84095

Copperview Medical Center Site Number : 8400038, South Jordan

85015

MedPharmics, LLC - Phoenix Site Number : 8400083, Phoenix

90057

Matrix Clinical Research Site Number : 8400095, Los Angeles

90241

Premier Health Research Center Site Number : 8400007, Downey

90255

Joint Clinical Trials Huntington Park Site Number : 8400126, Huntington Park

United Clinical Research Site Number : 8400092, Huntington Park

90723

Center for Clinical Trials, LLC Site Number : 8400030, Paramount

91790

Center for Clinical Trials of San Gabriel Site Number : 8400076, West Covina

92804

Emmaus Research Center, Inc Site Number : 8400031, Anaheim

97030

Cyn3rgy Research Site Number : 8400085, Gresham

454429

PriMed Clinical Research Site Number : 8400002, Dayton

76107-2699

University of North Texas Site Number : 8400079, Fort Worth

77555-0163

University of Texas Medical Board Site Number : 8400067, Galveston

77074-2085

Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114, Houston

84075-9143

Wee Care Pediatrics Syracuse Site Number : 8400024, Syracuse

84075-9645

Alliance for Multispecialty Research Syracuse Site Number : 8400036, Syracuse

00726

Investigational Site Number : 6300116, Caguas

000784

Investigational Site Number : 6300122, Guayama

00918

Investigational Site Number : 6300015, San Juan

Investigational Site Number : 6300117, San Juan

00935

Investigational Site Number : 6300140, San Juan

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT03537508 - Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US | Biotech Hunter | Biotech Hunter